Recall Z-2114-2018 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD Inc.
Bivona Tracheostomy Tube Tracheostomy Tubes
| Date | Apr 2, 2018 |
| Status | Terminated |
| Reason | Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile. |
| Root cause | Error in labeling |
| Action | Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form. |
| Quantity | 16 units |
| Distribution | Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.